Tumor-Treating Fields + Immunotherapy for Uveal Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new cancer treatment that uses electric fields to stop cancer cell growth. It targets patients with metastatic uveal melanoma, who often do not respond well to current treatments. The treatment works by boosting the immune system to help fight the cancer.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you haven't had certain cancer treatments recently and that any side effects from past treatments have resolved. It's best to discuss your specific medications with the trial team.
What safety information is available for Tumor-Treating Fields and Immunotherapy in humans?
Immune checkpoint inhibitors like Ipilimumab and Nivolumab can cause rare but serious eye-related side effects, such as uveitis (eye inflammation) and panuveitis, which may require treatment. In a study of Ipilimumab for uveal melanoma, some patients experienced immune-related side effects like diarrhea and liver enzyme changes, which were managed with steroids.12345
How is the Tumor-Treating Fields + Immunotherapy treatment for uveal melanoma different from other treatments?
This treatment is unique because it combines Tumor-Treating Fields, a non-invasive therapy that uses electric fields to disrupt cancer cell division, with immunotherapy drugs like Ipilimumab and Nivolumab, which help the immune system attack cancer cells. Unlike other treatments, this combination aims to enhance the body's natural defenses while directly targeting tumor growth.678910
What data supports the effectiveness of the treatment Tumor-Treating Fields + Immunotherapy for Uveal Melanoma?
The use of immune checkpoint inhibitors (ICI) like Ipilimumab and Nivolumab has shown improved survival rates in patients with metastatic uveal melanoma, with a one-year overall survival rate increasing from 25.0% to 41.9% after ICI treatment. Although response rates are lower compared to other melanoma types, these treatments have significantly improved real-world survival outcomes.6891112
Who Is on the Research Team?
Justin Moser, MD
Principal Investigator
HonorHealth Research Institute
Are You a Good Fit for This Trial?
This trial is for adults with metastatic uveal melanoma, mainly affecting the liver. Participants must be in good physical condition (ECOG 0-1), have a life expectancy of at least 3 months, and normal organ/marrow function. Women of childbearing potential must test negative for pregnancy and use contraception. Excluded are those with active autoimmune diseases requiring strong medication, recent cancer treatments, or severe reactions to immune checkpoint inhibitors.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Tumor Treating Fields in combination with nivolumab and ipilimumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
- Novocure Optune
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
HonorHealth Research Institute
Lead Sponsor
NovoCure Ltd.
Industry Sponsor
Ashley Cordova
NovoCure Ltd.
Chief Executive Officer
Bachelor of Science in Material Engineering from Ben-Gurion University of the Negev, Israel
Uri Weinberg
NovoCure Ltd.
Chief Medical Officer since 2020
MD from an unspecified institution